510(k) K083610
- Device
- FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE
- Applicant
- 3M COMPANY
- 510(k) number
- K083610
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-12-17
- Date received
- 2008-12-08
- Regulation
- 872.3690
- Classification name
- Material, Tooth Shade, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SCOTT ERICKSON
- Address
- 3m Center, Bldg. 275-2w-08 St. Paul MN US 55144 55144
FDA Registration Numbers#
- 3004130302
- 3032163716
- 3026400121
- 3032312561
- 1718912
- 3003310824
- 3000268902
- 3011689956
- 3008578884
- 3045857207
- 3032027578
- 1032227
- 9611514
- 3002807420
- 3018047916
- 3030515618
- 3001124136
- 2244842
- 9680845
- 9612352
- 3003637274
- 3012312751
- 3043226252
- 3008582406
- 3011430871
- 1410097
- 3016447764
- 2086043
- 3004425647
- 1450653
- 2916735
- 3006113314
- 3008494285
- 1000272892
- 9613375
- 8030452
- 3023816720
- 8010908
- 3024185724
- 3006316962
- 3011511773
- 3004967419
- 9680954
- 8020994
- 3022545323
- 1000118628
- 2515379
- 3005628474
- 3004491043
- 2424472
- 3006694515
- 2511556
- 2429849
- 3008005217
- 3014289665
- 3008882689
- 3010864832
- 3027526455
- 8030067
- 3009482106
- 3012389497
- 3015978392
- 1215305
- 1420052
- 3042244574
- 9613348
- 3000219976
- 3004966444
- 3006542438
- 9613953
- 9615399
- 3032378317
- 3008582054
- 3017183443
- 3024749697
- 3008912871
- 8044164
- 9612300
- 3013557697
- 3045891668
Source Documents#
Other 510(k) Records For Product Code EBF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262202 | Cerasmart Forte | GC America, Inc. | 2026-09-10 |
| K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) | Guilin Kevin Peter Technology Co., Ltd. | 2026-08-31 |
| K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. | 2026-07-01 |
| K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | 2026-07-01 |
| K261246 | SRGC-06 | GC America, Inc. | 2026-06-18 |
| K261093 | DIAFIL | DiaDent Group International | 2026-06-02 |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | DiaDent Group International | 2026-05-19 |
| K260805 | Dual Core | Vericom Co., Ltd. | 2026-05-11 |
| K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-27 |
| K261357 | Grandio disc multicolor | Voco GmbH | 2026-04-27 |
| K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | 2026-04-23 |
| K260661 | Midas Restore | Sprintray, Inc. | 2026-04-15 |
| K253036 | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2026-04-06 |
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | 2026-03-11 |
| K254245 | ZAFIRA® | New Stetic, SA | 2026-03-03 |
Legacy Summary#
summary
FDA Review#
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